Phase 3 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the ISRCTN registry eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have already completed the full dosing period in the original children's guselkumab study.
• People who, in the treating doctor's view, have continued to benefit from guselkumab treatment.
• People who are either not able to become pregnant, or if they could become pregnant, are either not sexually active or are using a highly reliable form of contraception (with a failure rate of less than 1% per year when used correctly), and agree to continue using it throughout the study and for at least 12 weeks after the last dose (confirm with trial site for approved methods).
• People who could become pregnant must agree not to donate eggs or freeze eggs for future fertility use during the study and for at least 12 weeks after the last dose.
• People who are capable of producing sperm must agree: if sexually active with someone who could become pregnant, to use a barrier method of contraception (such as a condom with spermicide); if sexually active with someone who is pregnant, to use a condom; and not to donate sperm during the study and for at least 12 weeks after the last dose.
• A parent or legal guardian (preferably both parents if available, or as required locally) must sign a consent form showing they understand the study and agree to allow their child to take part; children generally aged 7 and older who can understand the study must also give their own agreement, and young people who reach adulthood during the study will be asked to sign an adult consent form.
• People who are willing and able to follow the lifestyle guidelines set out in the study rules.

Who may not be able to join:

• People aged 18 or older living in a country where guselkumab has been approved for adults for more than 2 years, or people under 18 living in a country where guselkumab has been approved for children for more than 2 years.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study.
• People who have taken any medications or treatments that are not permitted under the study rules before the first planned dose in this extension study (confirm with trial site for the specific list).
• People who are employees of the study site or the supervising doctor and are directly involved in this or related studies, or who are close family members of such employees or the doctor.
• People who have any condition that the treating doctor believes would make participation unsafe, harmful to their wellbeing, or likely to interfere with the study assessments.

Important: Always verify eligibility with the trial site directly before applying.